Surgical sponges, particularly laparotomy sponges, are used extensively in medical procedures, from use as wipe cloths to saline-soaked packing for internal organs which are temporarily stored outside the body cavity during a surgical procedure. Literally millions of these sponges are used annually in the medical industry so that their cost is a very important consideration when examining the overall cost of medical care.
At the time of the manufacture of a medical sponge it is unknown where the sponge may be used, hence it is the common practice in the industry to include in the construction of the sponge at least one radiopaque element that is useful in identification of the sponge when viewed by X-ray. Placement of and adequate anchoring of this radiopaque element to or within the sponge has been problematical in the prior art. To the knowledge of the present inventor, except for those radiopaque elements which have been woven into the material of which the sponge is made or which have been heat-sealed to a sponge, only manual operations have been available to attach the radiopaque element to the sponge. Further, in the prior art sponges where a loop member is provided as a part of the sponge, the ends of the loop being anchored to the sponge at one edge or corner thereof as by stitching, the anchoring of the loop has heretofore been difficult to achieve. Among other desirable or required properties of absorbent articles intended for use in medical procedures, it is required that the article not exhibit cut yarn ends externally of the article where the ends could contact and irritate the patient's tissue, such as when using the article to clean an open wound or to absorb blood or other body fluids from an open body cavity during a surgical procedure. Further, loose yarns or pieces of yarns are not acceptable inasmuch as these act as foreign bodies when present internally of a patient, often resulting in granulomas or initiating other adverse effects.
U.S. Pat. No. 4,068,666 discloses a surgical sponge and method for forming the sponge in which multiple rectangular outer layers of absorbent material, e.g. cotton gauze and a special absorbent inner layer, are overlaid with their side edges in register. An elongated flat strip of radiopaque elastomeric element is laid on the top of the stack with one end of the strip aligned with the side edges of the absorbent material layers and the remainder of the strip projected inwardly of the stack, away from the side edges. This composite is next sewn along the side edges thereof, leaving a portion of the side edges unsewn. This sewing operation captures only one end of the radiopaque element in the stitching so that the remainder of the element is "loose" and can lose its flat profile during use and render the element difficult or even impossible to locate upon X-ray examination of the sponge. Further, the loose end of this element is subject to protrusion through the outer layer of gauze and presenting a highly objectionable source of possible tissue irritation or damage when the sponge is in use.
The sewn composite is then turned inside out, as one turns a bag inside out, through the opening developed by the unsewn portion of the side edges of the composite. This causes all raw edges of the composite layers to be turned inwardly of the composite, except for the unsewn portion of the side edges. This unsewn portion of the side edges is thereupon manually turned inwardly and sewn closed. In one embodiment, the ends of a flat fabric strip, in loop form, are positioned in the unsewn opening before it is sewn closed with the intent of anchoring such ends within the opening as it is sewn closed. The product of this patent has not been successfully marketed, primarily because the fabric loop is inadequately anchored to the sponge and breaks away when in use, and because of the very prohibitive cost of manufacturing the sponge which is occasioned by the large amount of manual labor required in its manufacture. Further, the corners of the loose end of the flat strip of radiopaque material, being in large part loose within the sponge, tended to project through the gauze material which formed to outer layer of the sponge and become a source of irritation to a patient when the corner digs into the patient's body tissue during use of the sponge. Also, as noted above, the loose element is subject to movement that may cause it to become difficult to locate using X-rays. The design and construction of this sponge precludes its manufacture using automatic mechanical means.
It is therefore an object of the present invention to provide a novel absorbent article, particularly a medical sponge.
It is another object of the present invention to provide a medical sponge which includes at least one radiopaque element and which is amenable to manufacture by automatic mechanical means.
It is another object of the present invention to provide a method for the manufacture of an absorbent article which includes a radiopaque element.
It is another object of the present invention to provide an improved laparotomy sponge having at least one radiopaque element securely anchored thereto.
These and other objects and advantages of the invention will be recognized by one skilled in the art given the present disclosure including the drawings in which: